Pharmacodynamics
Drotaverine is an isoquinoline derivative that exhibits a powerful antispasmodic effect on smooth muscle due to inhibition of the PDE-4 enzyme. Inhibition of the PDE-4 enzyme leads to an increase in the concentration of cAMP, inactivation of myosin light chain kinase, which subsequently causes relaxation of smooth muscles.
The effect of drotaverine in reducing the cytosolic concentration of Ca2+ ions through cAMP explains its antagonistic effect towards Ca2+ ions.
In vitro
drotaverine inhibits the PDE-4 enzyme without inhibiting the PDE-3 and PDE-5 enzymes. Therefore, the effectiveness of drotaverine depends on the concentrations of PDE-4 in different tissues. PDE-4 is most important for suppressing the contractile activity of smooth muscles, and therefore selective inhibition of PDE-4 may be useful for the treatment of hyperkinetic dyskinesias and various diseases accompanied by a spastic state of the gastrointestinal tract. The hydrolysis of cAMP in the myocardium and vascular smooth muscle occurs mainly with the help of the enzyme PDE-3, which explains the fact that with high antispasmodic activity, drotaverine has no serious side effects on the heart and blood vessels and no pronounced effects on the cardiovascular system. Drotaverine is effective against smooth muscle spasms of both neurogenic and muscular origin. Regardless of the type of autonomic innervation, drotaverine relaxes the smooth muscles of the gastrointestinal tract, biliary tract, genitourinary system, and blood vessels. Due to its vasodilating effect, drotaverine improves blood supply to tissues.
Thus, the mechanisms of action of drotaverine described above eliminate spasm of smooth muscles, which leads to a decrease in pain.
No-spa forte for abdominal pain tablets 80 mg No. 24
A country
Hungary
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.
Compound
1 tablet contains: active ingredient: drotaverine hydrochloride – 80 mg; excipients: magnesium stearate, talc, povidone, corn starch, lactose monohydrate. Description Oblong biconvex tablets, yellow with a greenish or orange tint, engraved “NOSPA” on one side and a break line on the other side. Release form Tablets 80 mg. 10 tablets in a blister made of aluminum foil/aluminum foil laminated with a polymer. 10 tablets per blister made of PVC/aluminum foil. 1 or 2 blisters along with instructions for use in a cardboard box. 24 tablets per blister made of PVC/aluminum foil. 1 blister along with instructions for use in a cardboard box.
Pharmacological properties
Pharmacodynamics Drotaverine is an isoquinoline derivative, similar in chemical structure and pharmacological properties to papaverine, but with a stronger and longer-lasting effect. Drotaverine has a powerful antispasmodic effect on smooth muscle due to inhibition of the enzyme phosphodiesterase (PDE). The enzyme phosphodiesterase is necessary for the hydrolysis of cAMP (cyclic adenosine-3´, 5´-monophosphate) to AMP (adenosine-5´-monophosphate). Inhibition of the phosphodiesterase enzyme leads to an increase in cAMP concentration, which triggers the following cascade reaction: high concentrations of cAMP activate cAMP-dependent phosphorylation of myosin light chain kinase (MLCK). Phosphorylation of MLCK leads to a decrease in its affinity for the Ca2+-calmodulin complex, resulting in an inactivated form of MLCK supporting muscle relaxation. cAMP, in addition, affects the cytosolic concentration of Ca2+ ion by stimulating the transport of Ca2+ into the extracellular space and the sarcoplasmic reticulum. This effect of drotaverine in lowering the cytosolic concentration of Ca2+ ion through cAMP explains its antagonistic effect towards Ca2+. In vitro, drotaverine inhibits the PDE IV isoenzyme without inhibiting the PDE III and PDE V isoenzymes. Therefore, the effectiveness of drotaverine depends on the concentrations of PDE IV in tissues, the content of which varies in different tissues. PDE IV is most important for suppressing the contractile activity of smooth muscles, and therefore selective inhibition of PDE IV may be useful for the treatment of hyperkinetic dyskinesias and various diseases accompanied by a spastic state of the gastrointestinal tract. The hydrolysis of cAMP in the myocardium and vascular smooth muscle occurs mainly with the help of the PDE III isoenzyme, which explains the fact that with high antispasmodic activity, drotaverine has no serious side effects on the heart and blood vessels and no pronounced effects on the cardiovascular system. Drotaverine is effective against smooth muscle spasms of both neurogenic and muscular origin. Regardless of the type of autonomic innervation, drotaverine relaxes the smooth muscles of the gastrointestinal tract, biliary tract, genitourinary system, and blood vessels. Due to its vasodilating effect, drotaverine improves blood supply to tissues. Pharmacokinetics: Compared with papaverine, drotaverine, when taken orally, is absorbed faster and more completely from the gastrointestinal tract. Absorption is 100%. However, after metabolism during the “first pass through the liver,” 65% of the dose taken enters the systemic circulation. Maximum plasma concentration (Cmax) is achieved after 45-60 minutes. In vitro, drotaverine is highly bound to plasma proteins (95-97%), especially with albumin, γ and β-globulins. Drotaverine is evenly distributed throughout the tissues and penetrates smooth muscle cells. Does not penetrate the blood-brain barrier. Drotaverine and/or its metabolites may slightly penetrate the placental barrier. In humans, drotaverine is almost completely metabolized in the liver by Odesethylation. Its metabolites quickly conjugate with glucuronic acid. The main metabolite is 4'-desethyldrotaverine, in addition to which 6-desethyldrotaverine and 4'-desethyldrotaveraldine have been identified. The half-life of drotaverine is 8-10 hours. Within 72 hours, drotaverine is almost completely eliminated from the body, more than 50% of the drug is excreted by the kidneys (mainly in the form of metabolites) and about 30% through the gastrointestinal tract (excretion into bile). Unchanged drotaverine is not detected in urine.
Indications for use
— Smooth muscle spasms in diseases of the biliary tract: cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, inflammation of the duodenal papilla. — Spasms of smooth muscles in diseases of the urinary tract: nephrolithiasis, urethrolithiasis, pyelitis, cystitis, bladder spasms. As an auxiliary therapy: - for spasms of smooth muscles of the gastrointestinal tract: peptic ulcer of the stomach and duodenum, gastritis, spasms of the cardia and pylorus, enteritis, colitis, spastic colitis with constipation and irritable bowel syndrome with flatulence; - for tensor headaches (tension headaches); - with algodismenorrhea.
Contraindications
— Hypersensitivity to drotaverine and/or excipients included in the drug. - Severe liver or kidney failure. - Severe heart failure (decreased cardiac output). — Breastfeeding period (see section “Pregnancy and lactation”). — Children's age (clinical studies have not been conducted in children). — Hereditary lactose intolerance, lactase deficiency, galactosemia or glucose/galactose malabsorption syndrome (due to the presence of lactose in the drug) (see “Special Instructions”). With caution - For arterial hypotension. — In pregnant women (see section “Pregnancy and lactation”). Pregnancy and lactation According to the limited amount of retrospective data on the use of the drug in humans and data from studies in animals when taking drotaverine orally, there is no evidence of its teratogenic or embryotoxic effect, or adverse effects on the course of pregnancy. Despite this, when using the drug in pregnant women, caution should be exercised and the drug should be prescribed only after carefully weighing the balance of benefits and risks for the mother and the risk for the child. Studies on the excretion of drotaverine into human milk in animals have not been conducted. Due to the lack of such studies in animals and clinical data, prescribing drotaverine during lactation is not recommended.
Mode of application
The drug is taken orally. Typically, the average daily dose is 120-240 mg (the daily dose is divided into 2-3 doses).
Side effect
The following side effects, which in clinical studies were regarded as at least possibly associated with drotaverine, are given in accordance with the following gradations of their frequency of occurrence: very often (1/10), often (≥1/100, 1/ 10); rarely (≥1/1000, 1/100); sometimes (≥1/10000, 1/1000); very rare (including isolated reports) ( 1/10000); unknown frequency (it is impossible to determine the frequency of occurrence from the available data) and are grouped by organ system. From the nervous system - Sometimes: headache, dizziness, insomnia. From the cardiovascular system - Sometimes: rapid heartbeat, decreased blood pressure. From the gastrointestinal tract - Sometimes: nausea, constipation. From the immune system - Sometimes - allergic reactions (angioedema, urticaria, rash, itching) (see section "Contraindications").
Overdose
Drotaverine overdose has been associated with cardiac rhythm and conduction disturbances, including complete bundle branch block and cardiac arrest, which can be fatal. In case of overdose, patients should be under medical supervision and, if necessary, they should receive symptomatic treatment aimed at maintaining basic body functions.
Interaction
With levodopa When used simultaneously, drotaverine can weaken the antiparkinsonian effect of levodopa, that is, increase rigidity and tremor. With papaverine, bendazole and other antispasmodics (including antispasmodics) Strengthening the antispasmodic effect. With morphine Reducing the spasmogenic activity of morphine. With phenobarbital Strengthening the antispasmodic effect of drotaverine.
special instructions
The use of the drug for arterial hypotension requires increased caution. Each tablet of No-shpa® forte contains 104 mg of lactose. When taken according to the recommended dosage regimen, up to 156 mg of lactose (1.5 tablets of No-shpa® forte) can be delivered with each dose, which can cause gastrointestinal disorders in patients suffering from lactose intolerance. This form of the drug is unacceptable for patients suffering from lactase deficiency, galactosemia or glucose/galactose malabsorption syndrome. Effect on the ability to drive a car and other mechanisms When taken orally in therapeutic doses, drotaverine does not affect the ability to drive vehicles and perform work that requires increased attention. If any side effects occur, the question of driving or engaging in other potentially hazardous activities requires individual consideration. If dizziness occurs, you should avoid engaging in potentially hazardous activities, such as driving vehicles and operating machinery.
Pharmacokinetics
Absorption.
Compared with papaverine, drotaverine, when taken orally, is quickly and more completely absorbed from the gastrointestinal tract. However, after first-pass metabolism, 65% of the administered dose of drotaverine enters the systemic circulation. Cmax of drotaverine in blood plasma is achieved after 45–60 minutes.
Distribution.
In vitro,
drotaverine is highly bound to plasma proteins (95–97%), especially albumin, γ- and β-globulins.
Drotaverine is evenly distributed in tissues and penetrates smooth muscle cells. Does not penetrate the BBB. Drotaverine and/or its metabolites may slightly penetrate the placental barrier.
Metabolism.
Drotaverine is almost completely metabolized in the liver.
Excretion.
T1/2 of drotaverine is 8–10 hours. Within 72 hours, drotaverine is almost completely eliminated from the body, about 50% of the drug is excreted by the kidneys (mainly in the form of metabolites) and about 30% through the gastrointestinal tract. The unchanged form of drotaverine is not detected in urine.
Pharmacological properties of the drug No-shpa forte
Drotaverine is an isoquinoline derivative antispasmodic that acts directly on smooth muscle by inhibiting PDE IV type and intracellular accumulation of cAMP, which leads to smooth muscle relaxation due to inactivation of myosin light chain kinase. In vitro, drotaverine inhibits the action of the PDE IV enzyme and inhibits the PDE III and PDE V isoenzymes. PDE IV is of great functional importance for reducing the contractile activity of smooth muscles, therefore selective inhibitors of this enzyme can be effective for the treatment of diseases accompanied by hypermobility, as well as various diseases, during which spasms of the gastrointestinal tract occur. In the smooth muscle cells of the myocardium and blood vessels, cAMP is hydrolyzed mainly by the PDE III isoenzyme, therefore drotaverine is an effective antispasmodic agent that does not have significant side effects on the cardiovascular system and a pronounced therapeutic effect on this system. Drotaverine is effective against smooth muscle spasms of both nervous and muscular origin. Drotaverine acts on the smooth muscles of the gastrointestinal, biliary, genitourinary and vascular systems, regardless of the type of their autonomous innervation. The product increases blood circulation in tissues due to its ability to dilate blood vessels. The effect of drotaverine is more pronounced than the effect of papaverine, absorption is faster and more complete, it binds less to serum proteins. The advantage of drotaverine is also that, unlike papaverine, after its parenteral administration there is no such side effect as stimulation of respiration. Drotaverine is quickly and completely absorbed both after parenteral and oral administration. To a large extent (95–98%) binds to blood plasma proteins, especially albumins, gamma and beta globulins. The maximum concentration is achieved within 45–60 minutes after oral administration. After passing through primary metabolism, 65% of the dose taken enters the blood circulation unchanged. Metabolized in the liver. The half-life is 8–10 hours. Within 72 hours, it is almost completely eliminated from the body, about 50% in the urine, 30% in the feces. Mainly - in the form of metabolites, unchanged in the urine is not detected.
Indications of the drug No-shpa® forte
spasms of smooth muscles in diseases of the biliary tract (cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, papillitis);
spasms of smooth muscles of the urinary tract (nephrolithiasis, urethrolithiasis, pyelitis, cystitis, bladder spasms).
As an adjuvant therapy for the following diseases and conditions:
spasms of smooth muscles of the gastrointestinal tract (peptic ulcer of the stomach and duodenum, gastritis, spasms of the cardia and pylorus, enteritis, colitis, spastic colitis with constipation, irritable bowel syndrome with flatulence);
tension headaches;
dysmenorrhea (menstrual pain).
No-spa forte tablet 80 mg pack cell cont x10
Marketing Authorization Holder: CHINOIN Pharmaceutical and Chemical Works Private, Co. Ltd. (Hungary)
Contacts for inquiries: SANOFI ATX code: A03AD02 (Drotaverine) Active substance: drotaverine (drotaverine) Rec.INN registered by WHO
Dosage form
NO-SHPA® FORTE
Tab. 80 mg: 10, 20 or 24 pcs.reg. No.: P N015632/01 dated 03/18/09 - Indefinitely Re-registration date: 04/13/18
Release form, packaging and composition of No-Shpa® Forte
The tablets are yellow with a greenish or orange tint, oblong, biconvex, with “NOSPA” engraved on one side and a break line on the other.
1 tab.
drotaverine hydrochloride 80 mg
Excipients: magnesium stearate, talc, povidone, corn starch, lactose monohydrate.
10 pieces. - blisters made of aluminum foil/aluminum foil laminated with polymer (1) - cardboard packs. 10 pieces. - blisters made of aluminum foil/aluminum foil laminated with polymer (2) - cardboard packs. 10 pieces. - blisters made of PVC/aluminum foil (1) - cardboard packs. 10 pieces. - PVC/aluminum foil blisters (2) - cardboard packs. 24 pcs. - blisters made of PVC/aluminum foil (1) - cardboard packs.
Clinical-pharmacological group: Myotropic antispasmodic Pharmaco-therapeutic group: Antispasmodic
pharmachologic effect
Drotaverine is an isoquinoline derivative, similar in chemical structure and pharmacological properties to papaverine, but with a stronger and longer-lasting effect. It has a powerful antispasmodic effect on smooth muscles due to inhibition of the PDE enzyme. The enzyme PDE is necessary for the hydrolysis of cAMP to AMP. Inhibition of PDE leads to an increase in cAMP concentration, which triggers the following cascade reaction: high concentrations of cAMP activate cAMP-dependent phosphorylation of myosin light chain kinase (MLCK). Phosphorylation of MLCK leads to a decrease in its affinity for the Ca2+-calmodulin complex, as a result of which the inactivated form of MLCK maintains muscle relaxation. In addition, cAMP affects the cytosolic concentration of Ca2+ ion by stimulating the transport of Ca2+ into the extracellular space and the sarcoplasmic reticulum. This lowering Ca2+ ion concentration effect of drotaverine through cAMP explains the antagonistic effect of drotaverine towards Ca2+.
In vitro, drotaverine inhibits the PDE4 isoenzyme without inhibiting the PDE3 and PDE5 isoenzymes. Therefore, the effectiveness of drotaverine depends on the concentration of PDE4 in tissues (the content of PDE4 in different tissues varies). PDE4 is most important for suppressing the contractile activity of smooth muscles, and therefore selective inhibition of PDE4 may be useful for the treatment of hyperkinetic dyskinesias and various diseases accompanied by a spastic state of the gastrointestinal tract.
The hydrolysis of cAMP in the myocardium and vascular smooth muscle occurs mainly with the help of the PDE3 isoenzyme, which explains the fact that with high antispasmodic activity, drotaverine has no serious side effects on the heart and blood vessels and no pronounced effects on the cardiovascular system.
Drotaverine is effective against smooth muscle spasms of both neurogenic and muscular origin. Regardless of the type of autonomic innervation, drotaverine relaxes the smooth muscles of the gastrointestinal tract, biliary tract, and genitourinary system.
Due to its vasodilating effect, drotaverine improves blood supply to tissues.
Pharmacokinetics
Suction
Compared with papaverine, drotaverine, when taken orally, is absorbed faster and more completely from the gastrointestinal tract. Absorption is 100%. After first-pass metabolism through the liver, 65% of the administered dose of drotaverine enters the systemic circulation. Cmax in blood plasma is reached after 45-60 minutes.
Distribution
In vitro, drotaverine is highly bound to plasma proteins (95-98%), especially albumin, β- and γ-globulins.
Drotaverine is evenly distributed in tissues and penetrates smooth muscle cells. Does not penetrate the BBB. Drotaverine and/or its metabolites are able to slightly penetrate the placental barrier.
Metabolism
In humans, drotaverine is almost completely metabolized in the liver by O-desethylation. Its metabolites quickly conjugate with glucuronic acid. The main metabolite is 4′-desethyldrotaverine, in addition to which 6-desethyldrotaverine and 4′-desethyldrotaveraldine have been identified.
Removal
T1/2 is 8-10 hours.
Within 72 hours, drotaverine is almost completely eliminated from the body. More than 50% of drotaverine is excreted by the kidneys and about 30% through the intestines (excretion into bile). Drotaverine is mainly excreted in the form of metabolites; unchanged drotaverine is not found in the urine.
Indications of the drug No-Shpa® Forte
spasms of smooth muscles in diseases of the biliary tract: cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, papillitis, spasms of smooth muscles of the urinary system: nephrolithiasis, urethrolithiasis, pyelitis, cystitis, bladder spasms.
As an adjuvant therapy:
for spasms of smooth muscles of the gastrointestinal tract: peptic ulcer of the stomach and duodenum, gastritis, spasms of the cardia and pylorus, enteritis, colitis, spastic colitis with constipation and irritable bowel syndrome with flatulence, tension headaches, algomenorrhea. ICD-10 codes
Dosage regimen
The drug is prescribed orally.
Typically, the average daily dose is 120-240 mg in 2-3 doses.
Side effect
The following side effects, which in clinical studies were considered to be at least possibly related to drotaverine, are listed according to the following frequency of occurrence: very common (≥1/10), common (≥1/100, <.1/10 ), rarely (≥1/1000, <.1/100), sometimes (≥1/10,000, <.1/1000), very rarely, including isolated reports (<.1/10,000), frequency unknown (according to The frequency of occurrence cannot be determined from the available data).
From the nervous system: sometimes – headache, dizziness, insomnia.
From the cardiovascular system: sometimes – rapid heartbeat, decreased blood pressure.
From the digestive system: sometimes – nausea, constipation.
From the immune system: sometimes - allergic reactions (itching, rash, urticaria, angioedema).
Contraindications for use
severe renal failure, severe liver failure, severe heart failure (reduced cardiac output), breastfeeding period, childhood (clinical studies have not been conducted in children), hereditary lactose intolerance, lactase deficiency, galactosemia, glucose-galactose malabsorption syndrome (due to presence of lactose in the tablets), hypersensitivity to drotaverine and/or auxiliary components of the drug.
Use the drug with caution in case of arterial hypotension and pregnancy.
Use during pregnancy and breastfeeding
According to a limited number of retrospective data on the use of the drug in humans and data from studies in animals, the use of drotaverine during pregnancy had neither teratogenic nor embryotoxic effects, nor adverse effects on the course of pregnancy. Despite this, during pregnancy the drug should be used with caution and only in cases where the potential benefit of therapy for the mother outweighs the possible risk to the fetus.
There have been no studies on the excretion of drotaverine in breast milk in animals, and clinical data are also lacking, so the drug is not recommended for use during lactation.
Use for liver dysfunction Contraindicated for use in severe liver failure.
Use for impaired renal function Contraindicated for use in severe renal failure.
Use in children The use of the drug in children is contraindicated (clinical studies have not been conducted in children).
special instructions
When using the drug in patients with arterial hypotension, increased caution is required.
Each tablet of No-shpa® forte contains 104 mg of lactose. When taken according to the recommended dosage regimen, up to 156 mg of lactose (1.5 tablets of No-shpa® forte) can be delivered with each dose, which can cause gastrointestinal disorders in patients suffering from lactose intolerance. This form of the drug is not suitable for patients with lactase deficiency, galactosemia or glucose/galactose malabsorption syndrome.
Impact on the ability to drive vehicles and operate machinery
When taken orally in therapeutic doses, drotaverine does not affect the ability to drive vehicles or perform work that requires increased concentration.
If any adverse reactions occur, the issue of driving and operating machinery requires individual consideration. If dizziness occurs after taking the drug, the patient should avoid engaging in potentially hazardous activities, such as driving vehicles and operating machinery.
Overdose
Drotaverine overdose has been associated with cardiac rhythm and conduction disturbances, including complete bundle branch block and cardiac arrest, which can be fatal.
Treatment: In case of overdose, patients should be under medical supervision. If necessary, symptomatic treatment aimed at maintaining the basic functions of the body should be carried out.
Drug interactions
When used simultaneously with drotaverine, it is possible to reduce the antiparkinsonian effect of levodopa, i.e. increased rigidity and tremor.
When used simultaneously, drotaverine enhances the antispasmodic effect of papaverine, bendazole and other antispasmodics (including m-anticholinergics).
With simultaneous use, drotaverine reduces the spasmogenic activity of morphine.
With simultaneous use, phenobarbital enhances the severity of the antispasmodic effect of drotaverine.
Storage conditions for No-Shpa® Forte
The drug should be stored out of the reach of children at a temperature not exceeding 25°C.
Shelf life of No-Shpa® Forte The shelf life for tablets in blisters made of aluminum foil/aluminum foil laminated with a polymer is 5 years, for tablets in blisters made of PVC/aluminum foil is 3 years. Do not use the drug after the expiration date indicated on the package.
Terms of sale
The drug is available without a prescription.
Contacts for inquiries
SANOFI
Representative office of Sanofi-aventis Group JSC (France)
125009 Moscow, Tverskaya st. 22 Tel. Fax
Contraindications
hypersensitivity to the active substance or to any of the excipients of the drug;
severe liver or kidney failure;
severe heart failure (low cardiac output syndrome);
hereditary galactose intolerance, lactase deficiency and glucose-galactose malabsorption syndrome (due to the presence of lactose monohydrate in the composition of the drug - see “Special Instructions”);
period of breastfeeding (see “Use during pregnancy and lactation”);
childhood.
Carefully:
arterial hypotension; pregnancy (see “Use during pregnancy and lactation”).
Use during pregnancy and breastfeeding
The studies conducted did not reveal the teratogenic and embryotoxic effects of drotaverine, as well as any adverse effects on the course of pregnancy. However, if it is necessary to use the drug No-shpa® forte during pregnancy, caution should be exercised and the drug should be prescribed only after assessing the ratio of the potential benefit to the mother and the possible risk to the fetus.
Due to the lack of animal studies and clinical data, it is not recommended to prescribe drotaverine during breastfeeding.
Side effects
Below are the adverse reactions observed in clinical studies, divided by organ system, indicating the frequency of their occurrence in accordance with the following gradations recommended by WHO: very often (≥10%); often (≥1; <10%); uncommon (≥0.1; <1%); rarely (≥0.01; <0.1%); very rare, including isolated reports (<0.01%); frequency unknown (frequency cannot be determined from available data).
From the nervous system:
rarely - headache, vertigo, insomnia; frequency unknown - dizziness.
From the SSS side:
rarely - palpitations, decreased blood pressure.
From the gastrointestinal tract:
rarely - nausea, constipation.
From the immune system:
rarely - allergic reactions (angioedema, urticaria, rash, itching) (see "Contraindications").
Side effects of the drug No-shpa forte
Side effects observed in clinical studies and caused by taking drotaverine are classified by organs and systems, as well as by frequency of occurrence: very often (≥1/10), often (≥1/100, but ≤1/10), infrequently (≥ 1/1000, but ≤1/100), rare (≥1/10,000, but ≤1/1000), very rare (≤1/10,000), including isolated cases. Gastrointestinal disorders: rarely - nausea, constipation. From the nervous system: rarely - headache, dizziness, insomnia. From the cardiovascular system: rarely - tachycardia, arterial hypotension. There are isolated reports of cases of allergic reactions, including angioedema.
Directions for use and doses
Inside.
The break line on the tablet is intended solely for breaking to make it easier to swallow.
1 table each for 1 dose 1–3 times a day. The maximum daily dose is 3 tablets. (which corresponds to 240 mg), the maximum single dose is 1 tablet. (which corresponds to 80 mg). When taking the drug without consulting a doctor, the recommended duration of taking the drug is usually 1-2 days. In cases where drotaverine is used as an adjuvant therapy, the duration of treatment without consulting a doctor may be longer (2-3 days). If pain persists, the patient should consult a doctor.
Method for assessing effectiveness.
If the patient can easily independently diagnose the symptoms of his disease, because... They are well known to him, then the effectiveness of treatment, namely the disappearance of pain, is also easily assessed by the patient. If there is a moderate or no improvement in pain within a few hours of taking the maximum single dose, or if the pain does not significantly decrease after taking the maximum daily dose, it is recommended to consult a doctor.
special instructions
The use of the drug for arterial hypotension requires increased caution.
Each tablet of No-shpa® forte contains 104 mg of lactose. Taking the drug according to the recommended dosage regimen may cause gastrointestinal disorders in patients suffering from lactose intolerance. This form of the drug is unacceptable for patients suffering from lactase deficiency, galactosemia or glucose/galactose malabsorption syndrome.
Impact on the ability to drive a car or perform work that requires increased speed of physical and mental reactions.
When taken orally in therapeutic doses, drotaverine does not affect the ability to drive a car or perform work that requires increased attention. If any side effects occur, the issue of driving and operating machinery requires individual consideration. If dizziness occurs, you should avoid engaging in potentially hazardous activities, such as driving or operating machinery.
Special instructions for the use of No-shpa forte
Each tablet of No-Shpa forte contains 104 mg of lactose. When used according to recommended doses, up to 156 mg of lactose can enter the body at one time, which can cause gastrointestinal complaints in patients with lactose intolerance. Do not use for the treatment of patients with congenital lactase deficiency, galactosemia or glucose-galactose malabsorption syndrome. Use during pregnancy and lactation. As shown by the results of retrospective clinical studies, oral administration of the drug did not cause a teratogenic or embryotoxic effect. However, caution should be exercised when prescribing the drug to women during pregnancy. Due to the lack of relevant research data, use of the drug during breastfeeding is not recommended. Children. The use of the drug for the treatment of children is contraindicated. The ability to influence the reaction rate when driving a vehicle or working with other mechanisms. If you experience dizziness after using the drug, you should refrain from driving or performing work that requires increased attention.
Manufacturer
Manufacturer and packer (primary packaging):
Hinoin Pharmaceutical and Chemical Products Plant CJSC, st. Levai 5, 2112 Veresegyház, Hungary.
Packer (secondary (consumer) packaging) and releasing quality control:
1. Hinoin Pharmaceutical and Chemical Products Plant CJSC, st. Levai 5, 2112 Veresegyház, Hungary.
2. JSC "ORTAT", Russia 157092, Kostroma region, Susaninsky district, village. Severnoye, Kharitonovo microdistrict.
Consumer complaints should be sent to the address in Russia: 125009, Moscow, st. Tverskaya, 22.
Tel.; Fax.
